Digital Quality Product Line Lead

MSD•Rahway, NJ

5d•Hybrid

About The Position

Own the Digital Quality Product Line vision and multi-year roadmap, aligned to Animal Health Quality, Lab, and IT strategies. Define and prioritize the product backlog based on enterprise value, regulatory risk, and business outcomes. Drive standardization and reuse of digital quality and lab capabilities across sites and regions. Lead the design, implementation, and global rollout of Quality and Lab digital products. Ensure solutions are fit-for-purpose, compliant, secure, and resilient throughout their lifecycle while maximizing value from existing platforms and identifying opportunities for enhancement, modernization, or rationalization. Ensure adherence to GxP regulations, Computer System Validation (CSV), and the transition toward CSA / OneCQV-aligned approaches. Act as the primary IT partner for Quality and Lab leadership, translating business needs into digital capabilities. Drive adoption through change management, training strategies, and communities of practice. Lead and develop product owners, solution leads, and delivery teams (internal and external). Scan for emerging technologies (AI/ML, automation, analytics) that enhance quality decision-making and lab efficiency.

Requirements

Bachelor’s degree in IT, Engineering, Life Sciences, or related field.
7+ years of experience in Quality, Laboratory, Manufacturing, or GxP IT environments.
Demonstrated experience leading digital product lines or large-scale platforms in regulated industries.
Strong knowledge of QMS, LIMS, SDLC, CSV/CSA, and inspection readiness.
Proven ability to lead global, cross-functional teams and influence senior stakeholders.
Apache Kafka
Apache Kafka
Benefits Management
Big Data
Big Data Analytics
Business Analysis
Business Process Improvements
Configuration Management (CM)
DevOps
Effort Estimation
Full Stack Development
Governance Management
GraphQL (Query Language)
GxP Regulations
IT Methodologies
Life Science
Microservices Architecture
Neo4j
Product Management Leadership
Program Management
Python (Programming Language)
RabbitMQ
Red Hat Ansible
Redis Database
Software Development

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

Own the Digital Quality Product Line vision and multi-year roadmap, aligned to Animal Health Quality, Lab, and IT strategies.
Define and prioritize the product backlog based on enterprise value, regulatory risk, and business outcomes.
Drive standardization and reuse of digital quality and lab capabilities across sites and regions.
Lead the design, implementation, and global rollout of Quality and Lab digital products.
Ensure solutions are fit-for-purpose, compliant, secure, and resilient throughout their lifecycle while maximizing value from existing platforms and identifying opportunities for enhancement, modernization, or rationalization.
Ensure adherence to GxP regulations, Computer System Validation (CSV), and the transition toward CSA / OneCQV-aligned approaches.
Act as the primary IT partner for Quality and Lab leadership, translating business needs into digital capabilities.
Drive adoption through change management, training strategies, and communities of practice.
Lead and develop product owners, solution leads, and delivery teams (internal and external).
Scan for emerging technologies (AI/ML, automation, analytics) that enhance quality decision-making and lab efficiency.